Stone filed her claim in the U.S. District Court for the Eastern District of Arkansas, alleging that the hernia mesh multi-layer coating is defective and an unreasonably dangerous design. According to Stone this sandwich design lead to a severe inflammatory response, fluid build up known as a seroma, movement of the patch and damage to abdominal tissue.

Stone received an Ethicon Physiomesh Composite mesh for a hernia repair surgery in 2011. Over the next few years, she developed severe bacterial infections and breakdown of the mesh requiring invasive surgery to fix.

Ethicon Physiomesh Hernia Mesh “Voluntary Recall”

After worldwide reports over the similar side effects from the Ethicon Physiomesh, Ethicon announced a voluntary recall in June 2016. But, in the United States, Ethicon removed the hernia mesh implants under the radar and labeled it as a “market withdrawal.”

What is the problem with the Ethicon Physiomesh?

Ethicon released its Physiomesh products in 2010, utilizing the U.S. Food & Drug Administration’s (FDA) 510(K) program. This “fast track” loophole allows a medical device to come to market without any human clinical trials, as long as a manufacturer can show that it is “substantially equivalent” to another product previously approved by the agency.

Ethicon Physiomesh claims a unique design with five distinct layers, that supposedly improves function. Ethicon Physiomesh has a sandwich design, with two layers of polyglecaprone-25, and two layers of polydioxanone film. The coating was applied to the polypropylene mesh to reduce adhesion, inflammation and help the mesh fix into the body.

According to experts, the design is defective in that the sandwich design and the Physiomesh coating blocks fluid to escape, causing seroma formation, infections, and other side effects.

Ethicon Physiomesh Hernia Mesh Multidistrict Litigation

The U.S. Judicial Panel on Multidistrict Litigation (JPML) recently approved Multidistrict Litigation or MDL to coordinate pretrial proceedings and centralizing all cases before U.S. District Judge Richard Story in the Northern District of Georgia.

Dr. Shezad Malik law firm continues to investigate Ethicon Physiomesh personal injury claims from across the country. If you or a loved have been injured by Ethicon Physiomesh, including perforation, pain, infections and redo surgery, please contact our office at 888-210-9693 immediately for your free consultation.

The Legal Examiner offers both bloggers and readers the opportunity to share their thoughts and opinions on all things law. From news on current legislative efforts to practical guidance on everyday legal issues, The Legal Examiner will have it covered. Learn More